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Date Added: Sat 01/07/2023

Study Director

Baguley, M23, UK
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Company: ADEPTO TECHNICAL RECRUITMENT LTD

Job Type: Permanent, FullTime

Salary: £40000/annum

Analytical Project Manager / Study Director - Pharma - North West

Our client has an opportunity for an experienced Analytical Project Manager / Study Director. They are globally respected analytical laboratory based in Manchester, which specialises in complex trace analytical chemistry. Experts in Extractables and leachables testing for the pharmaceutical, biopharmaceutical and medical device companies.

The successful candidate will be recognized for successful delivery of analytical chemistry studies conducted within a regulated environment (GLP/cGMP/ISO17025).

In this role, you will have responsibility for the design, conduct and reporting of regulatory and non-regulatory studies generating data to support the safety assessments for a range of end-user and medical device systems.

Responsibilities

* Responsible for the successful execution of studies in line with relevant regulatory and HSE requirements

* Good understanding of the requirements of GLP / cGMP / ISO17025

* Liaising with internal and external customers to communicate and ensure prompt and proper action on all aspects of studies

* Attending and, where appropriate, assisting in key elements of the work in assigned studies including monitoring progress and status

* Help to build and sustain a culture that drives employee engagement, creating an enjoyable place to work

* Participating in study-specific client visits as required

* Verify that studies are performed, documented and completed according to customer expectations and quality system requirements

* As needed, participation at professional conferences and presentations / meetings at customer sites

* Write or review controlled procedures including, but not limited to, SOPs, Process Instructions,

* Test Methods and material specifications

* Assist in delivering continuous improvement projects relating to, but not limited to, study design and conduct, as required

Skills / Qualifications

* Analytical chemistry degree or related subject

* Knowledge and experience directing analytical chemistry studies preferred

* Experience working in regulated environment (GLP / cGMP / ISO17025)

* Highly experienced project manager with a technical background or understanding

* Understanding of responsibilities of a study director within regulatory environment is essential

Company Overview

They are one of the fastest growing testing, inspection and certification businesses in the world. Globally they have more than 7,500 brilliant minds operating from 200 sites across 30 countries. Together they share an ambitious purpose to 'Make tomorrow safer than today
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